Mitigate Risk in Direct-to-Patient Distribution Models

Quite recently there has been a lot of media coverage about Sponsors considering the direct-to-patient model for delivery of clinical trial supplies in many therapeutic areas. It’s one sure way to empower the patient and make it a little easier for patient participation.

It is thought that direct-to-patient models drive efficiencies and improve the patient experience as it takes away the need for them to continually return to the investigator sites for their medication. For Sponsors, it can give peace of mind because the way in which patients take drug home from site. Currently, it presents a high level of uncontrolled variability even for 2-8◦ drug, not to mention cold chain supplies. Direct-to-patient takes the transportation burden away from the patient, which gives more assurance of product temperature and may reduce the Sponsor’s investigator site costs. However, it also presents many challenges for Sponsors, especially when cold chain supplies need to be shipped to individual patients in remote locations and across many countries.

As a first step, the Sponsor would need to carry out research to ensure that dispensing direct-to-patient is legal in countries included in the proposed protocol. Then, the Sponsor would need to include details of this new distribution model in their CTA submission. Additionally, if volumes of shipments need to get through customs clearance for countries that present import challenges or have the potential for delays, the Sponsor should consider using local depots in these countries. The local depot could then handle direct-to-patient dispatch of supplies, further accommodating any custom delivery requirements that individual patients may have.

In my opinion, the key to success lies in having excellent logistics support. These cold chain clinical supplies will be handled by multiple parties within the supply chain (e.g. couriers), many of whom may not fully appreciate the importance of maintaining these supplies in the correct temperature specification.

So how can we mitigate risk in direct-to-patient distribution models? Here are a few pointers:

Evaluate the capability of your supply chain partners, i.e. their ability to accommodate scheduled delivery times, especially if patients may only be at home for short periods of time during the day. Proactively monitor these deliveries, taking into account shipper expiry times.

Set up a means of regular communication with the patient re-shipment location/expected arrival.

Provide instructions to the patient on how to appropriately dispose of ancillaries, packaging, etc. Determine if there is a need to provide pick up and disposal services.

When supplies are being shipped to many countries, ensure all paperwork is provided in the local language as well as English and provide translation/interpreter services to facilitate all communication.

Patients may still want to communicate with the health professional at the investigator site. Consider technology that will enable the patient to communicate remotely and in real-time, e.g. Skype

Above all, have one point of contact available to deal with any logistics enquiries by phone and/or email.

For more information on these recommendations and other additional tips, please email me at elizabeth.gallagher@thermofisher.com or leave a comment below to let me know your thoughts on how to accommodate the direct-to-patient model.

Elizabeth is a seasoned pharmaceutical professional with experience and in-depth knowledge of clinical supplies packaging, labeling and distribution. Before joining Fisher Clinical Services, she was Director of Clinical Supply Operations for Daiichi Sankyo Pharma Development, the U.S. Research and Development operation of the global pharmaceutical company Daiichi Sankyo, Inc.
Her prior experience includes Director of Clinical Logistics at ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company. Elizabeth also worked in Johnson & Johnson’s Consumer Health and Biopharmaceutical divisions where she held a number of positions of increasing responsibility in clinical supplies throughout her successful 20-year career.